MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-01970311-PLS #D-QUADROX-I ADU. O.FILTER; DIFFUSIVE MEMBRANE OXYGENATOR

Catalog Number 70105.0758

Device Problem Filtration Problem (2941)

Patient Problems Hypoxia (1918); Pneumonia (2011)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

According to the customer: during v-v type ecmo procedure for the patient with diagnosis of pneumonia ((b)(4)), acute respiratory failure ((b)(4)) and septic shock ((b)(4)), our customer found some strange yellowish and wine-colored materials and film from the membrane after about 5 days since the first ecmo treatment.At the same time, pump flow had been slowed.Po2, pco2 and ph were also unstable and the value of spo2 was below 90%.In case of anticoagulation, heparin was used.Both leg color were changed (but circulation was detected on dpp) and no urine output, r/o crf (crrt for this patient) the patient was transferred to other hospital, nearby his home according to the patient's own intention.Crf means that chronic renal failure.I know that this has nothing to do with our oxygenator.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and corrective action for the device described in this report.The manufacturer has received the device for investigation on (b)(4) 2014.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

• Brand Name: BE-01970311-PLS #D-QUADROX-I ADU. O.FILTER
• Type of Device: DIFFUSIVE MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4090226
• MDR Text Key: 4746129
• Report Number: 8010762-2014-00258
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2014,07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 70105.0758
• Device Lot Number: 70097398
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 62